Nicotine UseNCT06851936
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
A study testing Nicotine cessation program in people with Nicotine Use and Tobacco Use, run by University of Florida at 1 site in United States.
Trial summary
Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use, Tobacco Use
- What is being tested?
- Nicotine cessation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cancer Survivors including Current Cancer Patients
- Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
- Any history of cancer diagnosis. Subjects currently receiving cancer-related treatments are eligible for enrollment.
- Receiving care from the participating UF Health clinics (Medical Oncology, Urology, and Radiation Oncology).
- Capable of completing study requirements
- Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
Show all 13Show fewer
- Adults aged ≥18 years
- Informal Caregivers/Family Members of Cancer Survivors
- Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
- A family member, informal caregiver, or friend of an enrolled cancer survivor receiving care from the participating UF Health clinics as described above
- Capable of completing study requirements
- Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
- Adults aged ≥18 years
Who cannot join
- Cancer Survivors including Current Cancer Patients
- Patients unable to complete the sessions because of language, travel or technology barriers
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Informal Caregivers/Family Members of Cancer Survivors
- Participants unable to complete the sessions because of language, travel or technology barriers
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Erika Barahona, M. Ed, 352-273-7345, ebarahona@ufl.edu
Jennifer LeLaurin, PhD
About this study
Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training.
Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.
- Conditions
- Nicotine Use, Tobacco Use
- Being tested
- Nicotine cessation program
- Keywords
- tobacco cessation, AHEC, cancer survivors, tobacco, nicotine
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine cessation programBehavioural
All participants will complete a nicotine cessation program designed by Area Health Education Center (AHEC). The focus is on known tobacco cessation techniques and motivations to quit with additional focuses on cancer survivors and caregivers. The program consists of 4 sessions (each session is approximately 60 minutes long) that will be delivered by a Tobacco Treatment Specialist by either videoconference or by telephone. Dyad enrollees (i.e., cancer survivors and their caregiver/family member) will complete sessions together. Participants will also be eligible for free nicotine replacement therapy while on study if medically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Cessation Program | Experimental | Not described Receives: Behavioral: Nicotine cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program reach for cancer survivors
Determine the reach of the nicotine cessation program used in this study for cancer survivors. This is defined as the proportion of eligible patients enrolled (i.e., agreed to participate and consented) during the study period.
Measured: Baseline
Secondary outcomes (9)
Program reach for caregivers/family members of cancer survivors
Determine the reach of the nicotine cessation program used in this study for caregivers/family members of cancer survivors. This is defined as the proportion of enrolled cancer survivors who also have a family member/caregiver enrolled.
Measured: Baseline
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Measured: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Measured: Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions
Clinic-level adoption of the study intervention
Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic
Measured: 18 months
Healthcare provider-level adoption of the study intervention
Determine the healthcare provider-level adoption of the study intervention, which is defined as the proportion of eligible healthcare providers participating in the healthcare provider training for this study.
Measured: 1-2 weeks
Participant satisfaction
Determine participant satisfaction with the nicotine cessation program used in this study, which will be measured using a 4-point Lickert scale.
Measured: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Participant adherence
Determine participant adherence to the nicotine cessation program used in this study, as measured by the number of sessions completed (out of 4).
Measured: 8 weeks after baseline assessment
Participant perspectives on program feasibility and acceptability
Assess participant perspectives on program feasibility and acceptability, using qualitative interviews.
Measured: Up to 4 weeks after program completion
Healthcare provider perspectives on intervention feasibility and acceptability
Assess healthcare provider perspectives on intervention feasibility and acceptability, using qualitative interviews.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start11 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine UseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer LeLaurin, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851936
- Sponsor's protocol ID
- UF-CCPS-039
- Other IDs
- IRB202500401
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT06851936
- Acronym / sponsor ID
- UF-CCPS-039
- Conditions
- Nicotine Use, Tobacco Use
- Keywords
- tobacco cessation, AHEC, cancer survivors, tobacco, nicotine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training.
Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Cessation Program | Experimental | Behavioral: Nicotine cessation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Cancer Survivors including Current Cancer Patients
- Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
- Any history of cancer diagnosis. Subjects currently receiving cancer-related treatments are eligible for enrollment.
- Receiving care from the participating UF Health clinics (Medical Oncology, Urology, and Radiation Oncology).
- Capable of completing study requirements
Key exclusion criteria (6 listed)
- Cancer Survivors including Current Cancer Patients
- Patients unable to complete the sessions because of language, travel or technology barriers
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Informal Caregivers/Family Members of Cancer Survivors
- Participants unable to complete the sessions because of language, travel or technology barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine cessation programAll participants will complete a nicotine cessation program designed by Area Health Education Center (AHEC). The focus is on known tobacco cessation techniques and motivations to quit with additional focuses on cancer survivors and caregivers. The program consists of 4 sessions (each session is approximately 60 minutes long) that will be delivered by a Tobacco Treatment Specialist by either videoconference or by telephone. Dyad enrollees (i.e., cancer survivors and their caregiver/family member) will complete sessions together. Participants will also be eligible for free nicotine replacement therapy while on study if medically appropriate. | Behavioural | Nicotine Cessation Program |
Primary outcome
Program reach for cancer survivors
Time frame: Baseline
Determine the reach of the nicotine cessation program used in this study for cancer survivors. This is defined as the proportion of eligible patients enrolled (i.e., agreed to participate and consented) during the study period.
9 secondary outcomes
Program reach for caregivers/family members of cancer survivors
Time frame: Baseline
Program effectiveness in tobacco cessation
Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Program effectiveness in tobacco cessation
Time frame: Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions
Clinic-level adoption of the study intervention
Time frame: 18 months
Healthcare provider-level adoption of the study intervention
Time frame: 1-2 weeks
Participant satisfaction
Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Participant adherence
Time frame: 8 weeks after baseline assessment
Participant perspectives on program feasibility and acceptability
Time frame: Up to 4 weeks after program completion
Healthcare provider perspectives on intervention feasibility and acceptability
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Related trials for Nicotine Use
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer LeLaurin, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine cessation program in people with Nicotine Use and Tobacco Use, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Barahona, M. Ed (352-273-7345, ebarahona@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program reach for cancer survivors (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.